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FDA 510(k)

KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR

K-Number: K962863 · 1996-11-19

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1996-11-19
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1996-11-19 under 510(k) number K962863. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR?

KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR is a medical device that received FDA 510(k) clearance on 1996-11-19. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K962863.

When did KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR receive FDA 510(k) clearance?

KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR received FDA 510(k) clearance on 1996-11-19, under 510(k) number K962863.

Who is the listed applicant for KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR?

The FDA product code for KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR is HIF.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII SystemK223923HOPKINS Telescopes

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Related Devices (Code: HIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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